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RECRUITING
NCT07486843
PHASE4

Preventing Structural Damage in Early Psoriatic Arthritis

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

Summary

Investigators hypothesize that TNFi is superior to SC MTX in preventing structural damage in early, treatment-naïve PsA, assessed using HR-pQCT. The study aims to ascertain: \- The effect of SC MTX and TNFi (adalimumab biosimilar) on erosion and enthesiophyte progression in early PsA by HR-pQCT. Participants will be: * Randomized in a 1:1 ratio to either the SC MTX group or the TNFi group. * HR-pQCT of MCPJ 2-4 will be performed at baseline, week 24, and one year. The primary outcome is the comparison of change in erosion volume over MCPJ 2-4 across 48 weeks between the SC MTX group (group 1) and the TNFi group (group 2), assessed by HR-pQCT.

Official title: Methotrexate Versus TNF Inhibition in Preventing Structural Damage in Early Psoriatic Arthritis: A Randomized Trial Using HR-pQCT (MeTEPsA Trial)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

108

Start Date

2026-03-16

Completion Date

2028-12-31

Last Updated

2026-03-23

Healthy Volunteers

No

Interventions

DRUG

Amgevita 40Mg Solution for Injection

Amgevita 40mg

DRUG

Methotrexate (Metoject® prefilled pen)

Metoject® PEN 7.5 mg, Metoject® PEN 10 mg, Metoject® PEN 15 mg, Metoject® PEN 20 mg, Metoject® PEN 25 mg

Locations (1)

The Chinese University of Hong Kong, Prince of Wales Hospital

Hong Kong, Hong Kong